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To determine whether silicone gel is effective at preventing or minimizing scar formation after eyelid surgery.
Upper eyelid blepharoplasty or ptosis repair is performed when the upper eyelid becomes droopy, which often occurs as a natural part of the aging process. The droopiness of the upper eyelids decreases the ability to see objects in their peripheral vision, causing functional deficits. Additionally, the droopiness can be a cosmetic concern for many. The most effective treatment option is blepharoplasty or ptosis repair.
During routine pre-operative counseling, many patients note a fear of prominent facial scarring. Different techniques have been described in the literature to minimize scarring, from steroid creams to injections to laser therapy; however, there is currently no consensus for long-term management of post-surgical eyelid scars. Specifically, there is no study examining the efficacy of topical silicone gel on eyelid scars, although a few studies have examined its efficacy on other facial scars. Silicone is proposed to aid in healing by regulating fibroblast production, reducing collagen production, and modifying expression of growth factors.
The investigator's study is designed to determine whether topical silicone may prevent significant post-operative eyelid scar formation. It may help clarify whether there is a safe and effective topical treatment for patients undergoing eyelid surgery for whom scarring or cosmesis is a concern. It is the first study of silicone gel on the eyelid and is also prospective, randomized, and double blinded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All patients | Other | Split-face study: patients undergoing bilateral eye surgery will have the sides of their face randomized to receive either placebo or silicone gel. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| silicone gel | Device | Patients who have consented to the study will receive two tubes labeled only "left" and "right", corresponding to the side of the face to which the tube contents will be applied. One tube will contain silicone gel and the other tube will contain aquaphor. Neither the patient nor the surgeon will know what side will receive which treatment. These tubes will be given to patients at post-operative week 1 visit. Patients will be instructed to rub the solution into their eyelid incisions gently with their fingers for 2-3 minutes twice a day |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative Scarring - Erythema | To determine whether silicone gel is effective at preventing or minimizing scar formation after eyelid surgery the appearance of post-operative Erythema, as graded by a blinded third-party physician using a questionnaire, was assessed at 1 week, 1 month, 3 months, and 6 months post-operatively. Physicians could choose between "1 = none", "2 = pink", and "3 = red". Higher mean scores are associated with increased redness. | Up to 6 months post-operation |
| Post-operative Scarring - Elevation | To determine whether silicone gel is effective at preventing or minimizing scar formation after eyelid surgery the appearance of post-operative Elevation, as graded by a blinded third-party physician using a questionnaire, was assessed at 1 week, 1 month, 3 months, and 6 months post-operatively. Physicians could choose between "1=no elevation", "2=minimal elevation (<0.5 mm)", and "3=definite elevation (>0.5 mm)". Higher mean scores are associated with increased elevation. | Up to 6 months post-operation |
| Post-operative Scarring - Pigmentation | To determine whether silicone gel is effective at preventing or minimizing scar formation after eyelid surgery the appearance of post-operative Pigmentation, as graded by a blinded third-party physician using a questionnaire, was assessed at 1 week, 1 month, 3 months, and 6 months post-operatively. Physicians could choose between "1=normal" and 2= hyper- or hypo-pigmentation". Higher/lower mean scores are associated with increased/decreased pigmentation, respectively. | 6 months post-operation |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Satisfaction | To determine whether silicone gel treatment has any effect on patient satisfaction with post-surgical eyelid scars patient satisfaction with post-operative scars was assessed at 1 week, 1 month, 3 months, and 6 months post-operatively via a questionnaire. Patients could choose between "1=very dissatisfied", "2=dissatisfied", "3=neutral", "4=satisfied", "5=very satisfied." | Up to 6 months post-operation |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative Firmness | Post-operative scar firmness was assessed at 1 week, 1 month, 3 months, and 6 months post-operatively via patient-reported surveys during follow-up visits. Patients could choose between "1=normal or soft/supple" and "2=hard". Higher mean scores are associated with increased firmness. | Up to 6 months post-operation |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne Barmettler | Montefiore Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27418806 | Background | Murdock J, Sayed MS, Tavakoli M, Portaliou DM, Lee WW. Safety and efficacy of a growth factor and cytokine-containing topical product in wound healing and incision scar management after upper eyelid blepharoplasty: a prospective split-face study. Clin Ophthalmol. 2016 Jun 30;10:1223-8. doi: 10.2147/OPTH.S109517. eCollection 2016. | |
| 20485035 |
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Based on the "split face" study design, there were 96 participants in each arm. Each participant served as their own control and had silicone gel applied to one eye and placebo treatment applied to the other eye. There was no attrition between consent/enrollment and randomization. Attrition after randomization is summarized in the tables below.
In this prospective, double-blinded split-face randomized study, patients who had already consented to undergoing surgical repair of upper eyelid ptosis or blepharoplasty were asked by the surgeon/principal investigator (PI) if they wished to participate in the study. The informed consent process took place in the PI's office after routine pre-operative counseling and discussion was performed for repair of upper eyelid ptosis or blepharoplasty.
| ID | Title | Description |
|---|---|---|
| FG000 | Silicone Gel Eye | Patients undergoing bilateral eye surgery will have the sides of their face randomized to receive either placebo or silicone gel. This arm includes the eye that received silicone gel. |
| FG001 | Placebo Eye | Patients undergoing bilateral eye surgery will have the sides of their face randomized to receive either placebo or silicone gel. This arm includes the eye that received placebo (petrolatum ointment). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline demographic information was obtained for the 96 patients who completed the study.
| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Patients undergoing bilateral eye surgery will have the sides of their face randomized to receive either placebo (petrolatum ointment) or silicone gel. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Post-operative Scarring - Erythema | To determine whether silicone gel is effective at preventing or minimizing scar formation after eyelid surgery the appearance of post-operative Erythema, as graded by a blinded third-party physician using a questionnaire, was assessed at 1 week, 1 month, 3 months, and 6 months post-operatively. Physicians could choose between "1 = none", "2 = pink", and "3 = red". Higher mean scores are associated with increased redness. | Posted | Mean | Standard Deviation | score on a scale | Up to 6 months post-operation | Eyes | Eyes |
|
From enrollment to 6 months post-operation
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Silicone Gel Eye | Patients undergoing bilateral eye surgery will have the sides of their face randomized to receive either placebo or silicone gel. This arm includes the eye that received silicone gel. |
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Limitations in sample size, follow-up time, and subject retention should be noted. Future studies in this area could include extended follow-up periods, larger sample sizes, and exploration of combination therapies, such as silicone gel in conjunction with other modalities of scar management.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Anne Barmettler | Montefiore Medical Center | 7189205561 | annebarmett@montefiore.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 16, 2018 | Dec 11, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 17, 2024 | Dec 11, 2025 | ICF_001.pdf |
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|
| Post-operative Itching | Post-operative Itching was assessed at 1 week, 1 month, 3 months, and 6 months post-operatively via patient-reported surveys during follow-up visits. Patients could choose between "1=none", "2=occasional", and "3=requires medication". Higher mean scores are associated with increased itching. | Up to 6 months post-operation |
| Post-Operative Pain | Post-operative Pain was assessed at 1 week, 1 month, 3 months, and 6 months post-operatively via patient-reported surveys during follow-up visits. Patients could choose between "1=none", "2=occasional", and "3=requires medical attention". Higher mean scores are associated with increased pain. | Up to 6 months post-operation |
| Patient Scar Preference | To determine whether silicone gel treatment has any effect on patient preference of post-surgical eyelid scar treatment, patient preference with scars at 1 week, 1 month, and 6 months post-operation was assessed by a questionnaire. Blinded patients could choose "right" or "left" or "neither". Non-blinded coders then converted patient responses to "Silicone Gel treatment preferred" or "Placebo treatment preferred" or "Neither treatment preferred" based on each patient's eye randomization. The number of patients in each categorical variable is summarized by study arm. | 6 months post-operation |
| Bianchi FA, Roccia F, Fiorini P, Berrone S. Use of Patient and Observer Scar Assessment Scale for evaluation of facial scars treated with self-drying silicone gel. J Craniofac Surg. 2010 May;21(3):719-23. doi: 10.1097/SCS.0b013e3181d841af. |
| 24091488 | Background | Yun IS, Yoo HS, Kim YO, Rah DK. Improved scar appearance with combined use of silicone gel and vitamin C for Asian patients: a comparative case series. Aesthetic Plast Surg. 2013 Dec;37(6):1176-81. doi: 10.1007/s00266-013-0210-5. Epub 2013 Oct 3. |
| 20808600 | Background | Puri N, Talwar A. The efficacy of silicone gel for the treatment of hypertrophic scars and keloids. J Cutan Aesthet Surg. 2009 Jul;2(2):104-6. doi: 10.4103/0974-2077.58527. |
| eyes |
|
| Years |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants | No | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | No | Participants |
|
| Region of Enrollment | Number | participants | Participants |
|
Patients undergoing bilateral eye surgery will have the sides of their face randomized to receive either placebo or silicone gel. This arm includes the eye that received placebo (petrolatum ointment). |
|
|
|
| Primary | Post-operative Scarring - Elevation | To determine whether silicone gel is effective at preventing or minimizing scar formation after eyelid surgery the appearance of post-operative Elevation, as graded by a blinded third-party physician using a questionnaire, was assessed at 1 week, 1 month, 3 months, and 6 months post-operatively. Physicians could choose between "1=no elevation", "2=minimal elevation (<0.5 mm)", and "3=definite elevation (>0.5 mm)". Higher mean scores are associated with increased elevation. | Posted | Mean | Standard Deviation | score on a scale | Up to 6 months post-operation | Eyes | Eyes |
|
|
|
|
| Primary | Post-operative Scarring - Pigmentation | To determine whether silicone gel is effective at preventing or minimizing scar formation after eyelid surgery the appearance of post-operative Pigmentation, as graded by a blinded third-party physician using a questionnaire, was assessed at 1 week, 1 month, 3 months, and 6 months post-operatively. Physicians could choose between "1=normal" and 2= hyper- or hypo-pigmentation". Higher/lower mean scores are associated with increased/decreased pigmentation, respectively. | Posted | Mean | Standard Deviation | score on a scale | 6 months post-operation | Eyes | Eyes |
|
|
|
|
| Secondary | Patient Satisfaction | To determine whether silicone gel treatment has any effect on patient satisfaction with post-surgical eyelid scars patient satisfaction with post-operative scars was assessed at 1 week, 1 month, 3 months, and 6 months post-operatively via a questionnaire. Patients could choose between "1=very dissatisfied", "2=dissatisfied", "3=neutral", "4=satisfied", "5=very satisfied." | Posted | Mean | Standard Deviation | score on a scale | Up to 6 months post-operation |
|
|
|
|
| Secondary | Post-operative Itching | Post-operative Itching was assessed at 1 week, 1 month, 3 months, and 6 months post-operatively via patient-reported surveys during follow-up visits. Patients could choose between "1=none", "2=occasional", and "3=requires medication". Higher mean scores are associated with increased itching. | Posted | Mean | Standard Deviation | score on a scale | Up to 6 months post-operation | Eyes | Eyes |
|
|
|
|
| Secondary | Post-Operative Pain | Post-operative Pain was assessed at 1 week, 1 month, 3 months, and 6 months post-operatively via patient-reported surveys during follow-up visits. Patients could choose between "1=none", "2=occasional", and "3=requires medical attention". Higher mean scores are associated with increased pain. | Posted | Mean | Standard Deviation | score on a scale | Up to 6 months post-operation | Eyes | Eyes |
|
|
|
|
| Secondary | Patient Scar Preference | To determine whether silicone gel treatment has any effect on patient preference of post-surgical eyelid scar treatment, patient preference with scars at 1 week, 1 month, and 6 months post-operation was assessed by a questionnaire. Blinded patients could choose "right" or "left" or "neither". Non-blinded coders then converted patient responses to "Silicone Gel treatment preferred" or "Placebo treatment preferred" or "Neither treatment preferred" based on each patient's eye randomization. The number of patients in each categorical variable is summarized by study arm. | The totals in the table demonstrate the number of participants who completed the Patient Scar Preference question at each timepoint. | Posted | Count of Participants | Participants | 6 months post-operation |
|
|
|
| Other Pre-specified | Post-operative Firmness | Post-operative scar firmness was assessed at 1 week, 1 month, 3 months, and 6 months post-operatively via patient-reported surveys during follow-up visits. Patients could choose between "1=normal or soft/supple" and "2=hard". Higher mean scores are associated with increased firmness. | Posted | Mean | Standard Deviation | score on a scale | Up to 6 months post-operation | eyes | eyes |
|
|
|
|
| 0 |
| 96 |
| 0 |
| 96 |
| 0 |
| 96 |
| EG001 | Placebo Eye | Patients undergoing bilateral eye surgery will have the sides of their face randomized to receive either placebo or silicone gel. This arm includes the eye that received placebo (petrolatum ointment). | 0 | 96 | 0 | 96 | 0 | 96 |
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| Month 3 |
|
| Month 6 |
|
| 0.30 |
| Mean Difference (Final Values) |
| 0.09 |
| 2-Sided |
| 95 |
| -0.07 |
| 0.25 |
| Superiority |
| 3 Month timepoint | Wilcoxon (Mann-Whitney) | 1.00 | Mean Difference (Final Values) | 0.00 | 2-Sided | 95 | -0.23 | 0.23 | Superiority |
| 6 Month timepoint | Wilcoxon (Mann-Whitney) | 1.00 | Mean Difference (Final Values) | 0.00 | 2-Sided | 95 | 0.00 | 0.00 | Superiority |
| Month 3 |
|
| Month 6 |
|
| 1.00 |
| Mean Difference (Final Values) |
| -0.03 |
| 2-Sided |
| 95 |
| -0.16 |
| 0.11 |
| Superiority |
| 3 Month Timepoint | McNemar | 1.00 | Mean Difference (Final Values) | 0.06 | 2-Sided | 95 | -0.06 | 0.17 | Superiority |
| 6 Month Timepoint | McNemar | 1.00 | Mean Difference (Final Values) | -0.09 | 2-Sided | 95 | -0.29 | 0.11 | Superiority |
| Month 3 |
|
| Month 6 |
|
| 1.00 |
| Mean Difference (Final Values) |
| 0.00 |
| 2-Sided |
| 95 |
| -0.24 |
| 0.24 |
| Superiority |
| 3 Month Timepoint | Wilcoxon (Mann-Whitney) | 1.00 | Mean Difference (Final Values) | -0.05 | 2-Sided | 95 | -0.25 | 0.14 | Superiority |
| 6 Month Timepoint | Wilcoxon (Mann-Whitney) | 0.77 | Mean Difference (Final Values) | 0.09 | 2-Sided | 95 | -0.38 | 0.56 | Superiority |
| Month 3 |
|
| Month 6 |
|
| 0.53 |
| Mean Difference (Final Values) |
| 0.06 |
| 2-Sided |
| 95 |
| -0.11 |
| 0.23 |
| Superiority |
| 3 Month timepoint | Wilcoxon (Mann-Whitney) | 0.77 | Mean Difference (Final Values) | -0.05 | 2-Sided | 95 | -0.25 | 0.14 | Superiority |
| 6 Month timepoint | Wilcoxon (Mann-Whitney) | 1.00 | Mean Difference (Final Values) | 0.09 | 2-Sided | 95 | -0.11 | 0.29 | Superiority |
| Month 3 |
|
| Month 6 |
|
| 1.00 |
| Mean Difference (Final Values) |
| 0.03 |
| 2-Sided |
| 95 |
| -0.03 |
| 0.09 |
| Superiority |
| 3 Month timepoint | Wilcoxon (Mann-Whitney) | 1.00 | Mean Difference (Final Values) | -0.05 | 2-Sided | 95 | -0.16 | 0.06 | Superiority |
| 6 Month timepoint | Wilcoxon (Mann-Whitney) | 1.00 | Mean Difference (Final Values) | 0.00 | 2-Sided | 95 | 0.00 | 0.00 | Superiority |
| Neither treatment preferred |
|
| Month 1 |
|
|
| Month 3 |
|
|
| Month 6 |
|
|
| Month 3 |
|
| Month 6 |
|
| 0.27 |
| Mean Difference (Final Values) |
| -0.12 |
| 2-Sided |
| 95 |
| -0.34 |
| 0.11 |
| Superiority |
| 3 Month timepoint | Wilcoxon (Mann-Whitney) | 1.00 | Mean Difference (Final Values) | 0.05 | 2-Sided | 95 | -0.06 | 0.16 | Superiority |
| 6 Month timepoint | Wilcoxon (Mann-Whitney) | 1.00 | Mean Difference (Final Values) | 0.00 | 2-Sided | 95 | 0.00 | 0.00 | Superiority |